FDA 510(k) Application Details - K032967

Device Classification Name Tonometer, Manual

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510(K) Number K032967
Device Name Tonometer, Manual
Applicant SMT SWISS MICROTECHNOLOGY AG
13 RED FOX LANE
LITTLETON, CO 80127 US
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Contact Kevin Walls
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Regulation Number 886.1930

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Classification Product Code HKY
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Date Received 09/23/2003
Decision Date 11/14/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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